Diclofenac sodium

Product NDC: 80425-0414
Requested package NDC: 80425-0414-1
11-digit product format: 804250414
Labeler code: 80425
Product ID: 80425-0414_1d4d39a7-d22b-aa13-e063-6294a90a05f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA216275
Marketing category: ANDA
Marketing start: 2024-07-11
Substance: DICLOFENAC SODIUM
Active strength: 100 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216275-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2022-09-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A216275-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216275-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-09-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216275-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216275-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216275-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216275-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216275-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216275-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216275-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216275-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216275-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216275-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216275-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216275-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216275-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216275-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216275-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216275-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216275-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216275-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216275-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216275-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216275-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216275-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216275-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216275-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216275-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216275-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216275-001	AB	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216275-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QTG126297Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855657	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1d4d6370-2b45-fa6d-e063-6294a90a4a67	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0414-1	Diclofenac sodium	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	1
80425-0414-2	Diclofenac sodium	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	1
80425-0414-3	Diclofenac sodium	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0414-1	EA - Each	80425-0414	0a978265-5f78-4a27-9270-21b9667ed643	1	2024-08-12
80425-0414-2	EA - Each	80425-0414	35406b09-85d0-456c-aaf7-bfab9170221c	1	2024-08-12
80425-0414-3	EA - Each	80425-0414	97b0db2e-5d82-4941-b8fa-09e49aa75a56	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0414	DICLOFENAC SODIUM TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]	1	Current NDC, 3 package rows	20240716_1d4d6370-2b45-fa6d-e063-6294a90a4a67.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	6980431d-4a2b-41e9-ae86-d46b4513f04b	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275
Diclofenac sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	b28e4a68-f396-4c1a-ba38-6a972906b4d0	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275
Diclofenac sodium	DICLOFENAC SODIUM	Sportpharm LLC	99f1e69e-02cf-49c2-83af-3cccbbea4215	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275
Diclofenac sodium	DICLOFENAC SODIUM	Ingenus Pharmaceuticals, LLC	1a237198-ca24-4159-b570-b5a23c8e91b0	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275
Diclofenac sodium	DICLOFENAC SODIUM	BluePoint Laboratories	896e3f7d-88e6-4563-b879-a2757d19fd62	2025-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275
Diclofenac sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	1d4d6370-2b45-fa6d-e063-6294a90a4a67	2024-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275 ndc (package): 80425-0414-1 ndc (product): 80425-0414 ndc11 (package): 80425041401
Diclofenac sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	6a9c3cea-7b46-427d-99af-90c1f290b190	2023-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216275 application number: ANDA216275

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855657	diclofenac sodium 100 MG 24HR Extended Release Oral Tablet	PSN	1d4d6370-2b45-fa6d-e063-6294a90a4a67	1
855657	24 HR diclofenac sodium 100 MG Extended Release Oral Tablet	SCD	1d4d6370-2b45-fa6d-e063-6294a90a4a67	1
855657	diclofenac sodium 100 MG 24 HR Extended Release Oral Tablet	SY	1d4d6370-2b45-fa6d-e063-6294a90a4a67	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80425-0414-1	80425041401	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0414-1)	2024-07-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Extended-Release Tablets USP Rx only Prescribing Information	Advanced Rx of Tennessee, LLC	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	1